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FDA 510(k)

Blue Beacon Submucosal Injectable Solution

K-Number: K200071 · 2020-11-03

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2020-11-03
Product CodePLL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Blue Beacon Submucosal Injectable Solution is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2020-11-03 under 510(k) number K200071. The device is classified under product code PLL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blue Beacon Submucosal Injectable Solution?

Blue Beacon Submucosal Injectable Solution is a medical device that received FDA 510(k) clearance on 2020-11-03. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K200071.

When did Blue Beacon Submucosal Injectable Solution receive FDA 510(k) clearance?

Blue Beacon Submucosal Injectable Solution received FDA 510(k) clearance on 2020-11-03, under 510(k) number K200071.

Who is the listed applicant for Blue Beacon Submucosal Injectable Solution?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blue Beacon Submucosal Injectable Solution?

The FDA product code for Blue Beacon Submucosal Injectable Solution is PLL.

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Related Devices (Code: PLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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